Luminex Verigene Processor SP Recalled for Potential False Negative Results
Luminex is recalling Verigene Processor SP systems because an instrument failure may cause false negative results in blood culture tests.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may produce false negative diagnostic results, which is a risk-of-harm scenario where injury or adverse health consequences have not yet been reported.
Plain-English summary
Luminex Corporation is recalling 3,016 Verigene Processor SP systems, including both new and refurbished units, due to a potential instrument failure mode. The affected devices are used with the VERIGENE Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) and the Blood Culture Gram Positive (BC-GP) assay.
The recall is issued because the instrument failure may result in a false negative call for these blood culture tests. A false negative result could lead to a failure to detect a bacterial infection in a patient's blood sample.
The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries. Healthcare facilities and laboratories that have these specific serial numbers should stop using the affected instruments and contact Luminex Corporation for further instructions on remediation or replacement.
The recalled product
- Product
- Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
- Manufacturer
- Luminex Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Verigene Processor SP
- 10-0000-07
- GTIN 00840487101483
- Serial Numbers: 902
- 907
- 908
- 909
- 911
- 912
- 9098001
- 9098002
- 9098003
- 9098005
- 9098006
- 9100009
- 9100011
- 9100012
- 9100014
- 9121015
- 9121017
Distribution
Part of a larger recall action
This product is one of 2 recalled by Luminex Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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